High Ischemic Risk and Bleeding Risk: A Delicate Balance Post-PCI

More than half of patients who underwent PCI at a single center in China met criteria for being at high risk for subsequent ischemic events, and the presence of these high-ischemic-risk (HIR) characteristics was indeed associated with worse clinical outcomes, a new real-world analysis confirms.

Moreover, this subsequent risk of ischemic events, which was based on criteria from the European Society of Cardiology and European Association for Cardio-Thoracic Surgery (ESC/EACTS), does not appear to be modified by the patient’s baseline risk for bleeding.

When patients were stratified according to their bleeding risk by PRECISE-DAPT score, there remained a consistent effect of the HIR features on ischemic events in patients at very low, low, moderate, and high risk for bleeding, with no evidence of a statistically significant interaction. The findings underscore “the importance of applying the ESC/EACTS-criteria judgement when tailoring the duration of [dual antiplatelet therapy (DAPT)],” said lead investigator Hao-Yu Wang, MD (Fuwai Hospital/Peking Union Medical College, Beijing, China).   

Wang presented the analysis last week at the European Atherosclerosis Society Congress 2021.

In the 2018 ESC/EACTS guidelines for myocardial revascularization, the writing committee endorsed a number of features known to increase the risk of ischemic events after PCI. These include procedural characteristics such as implanting more than three stents, treating more than three lesions, total stent length > 60 mm, bifurcation with two stents implanted, and treatment of chronic total occlusions. Diabetic patients with diffuse multivessel disease, those with chronic kidney disease, and those with history of STEMI or stent thrombosis despite adequate antiplatelet therapy are also at high risk of ischemic events.

Presenting the results of their study, Wang said it’s unknown if high-bleeding-risk (HBR) status moderates the risk of adverse events for patients with HIR features. With that in mind, they assessed the clinical outcomes of 10,167 patients who underwent PCI in 2013 at a single center in Beijing, China. Of these, 50.6% of patients had at least one ESC/EACTS-endorsed criteria for HIR, the most common being more than three stents (23.5%) followed by total stent length > 60 mm (20.2%), diffuse multivessel disease in diabetics (18.5%), and history of STEMI (13.9%).

One-quarter of patients had at least two HIR features, 17.5% had three features, and 11.1% had four or more HIR features. 

Compared with those who lacked any HIR characteristics, those at HIR had significantly higher risks of target vessel failure (HR 1.48; 95% CI 1.25-1.74) and the combined patient-oriented composite endpoint (POCE) of all-cause mortality, any myocardial infarction, and any revascularization (HR 1.44; 95% CI 1.28-1.63). The risk increased with increasing number of HIR characteristics when modeled as a continuous variable (HR 1.12; 95% CI 1.05-1.19). There was no difference in the risk of clinically relevant bleeding among those with HIR, even among those with two or more HIR characteristics. Regarding the individual characteristics, just procedures with total stent length > 60 mm and the treatment of multivessel disease in diabetic patients were independent predictors of TVF and POCE, and neither were associated with clinically relevant bleeding.  

Overall, bleeding risk had no impact on the risk of ischemic events. For example, the relative increased risk of TVF in patients with HIR features versus those without HIR was consistent in patients at low and high risk of bleeding. Additionally, the relative increased risk of POCE in patients with versus without HIR was similar no matter whether they did or didn’t have a heightened risk of bleeding. Overall, there was no increased risk of clinically relevant bleeding in patients with HIR versus non-HIR irrespective of baseline bleeding risk. 

Given the absence of an interplay between HIR and HBR, Wang said the data reinforce the idea that ESC/EACTS criteria for HIR can inform choices over DAPT duration. He noted this is the first time the score has been validated in a large, unselected patient population undergoing PCI. The study also shows that patients with HIR are more frequently encountered in clinical practice—slightly more than half of patients in their cohort had high-risk features—than in clinical trials.